GeneratorElutionPredictor

Generator Elution Predictor

decay correction endotoxins PET radionuclide purity radiopharma SPECT sterility
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Generator Elution Predictor — Generator elution activity predictor

ℹ️  Utility calculates PREDICTED daughter nuclide activity in generator eluate:
    • Accounts for parent nuclide decay since calibration
    • Accounts for daughter nuclide ingrowth between elutions
    • Applies elution efficiency to calculate activity in eluate
    • Estimates number of possible patient doses

⚠️  IMPORTANT: Result is a PREDICTION and does NOT replace activity measurement
    before clinical use. Used for production planning and assessment of activity
    sufficiency for scheduled studies.

Usage:
  GeneratorElutionPredictor.exe                            → demo mode (console output)
  GeneratorElutionPredictor.exe input.csv output.json      → calculate with your data

Input format:
BatchNumber,GeneratorType,GeneratorCalibrationActivityMBq,CalibrationDateTime,LastElutionDateTime,NextElutionDateTime,ElutionEfficiencyPercent,DosePerPatientMBq

Examples:
  TC99M-GEN-2026-001,Mo99-Tc99m,30000.0,2026-03-17T08:00:00,2026-03-18T08:00:00,2026-03-19T08:00:00,80.0,750.0
  GA68-GEN-2026-001,Ge68-Ga68,1850.0,2026-03-01T08:00:00,2026-03-18T08:00:00,2026-03-18T14:00:00,60.0,200.0
  RB82-GEN-2026-001,Sr82-Rb82,3700.0,2026-03-10T08:00:00,2026-03-18T08:00:00,2026-03-18T09:00:00,90.0,1500.0

— WHY IS THIS NEEDED?
Generator elution planning is critical in radiopharmacy:
• For diagnostic generators (Mo-99/Tc-99m) — ensuring sufficient activity for all
  scheduled studies during the day
• For therapeutic/PET generators (Ge-68/Ga-68, Sr-82/Rb-82) — optimizing elution timing
  for maximum activity with minimal losses
• For inventory management — deciding when to order a new generator
• For documentation — activity prediction for reporting and audits

⚠️ CRITICAL:
• Utility uses PHYSICAL decay model accounting for transient equilibrium
• Formula: A_d(t) = A_p(0) × [λ_d / (λ_d - λ_p)] × [1 - e^(-(λ_d - λ_p)×t)] × e^(-λ_p×t)
• Requires knowledge of PARENT nuclide activity at generator calibration
  (provided in generator certificate by manufacturer)
• Elution efficiency varies by generator type and method:
  — Mo-99/Tc-99m: 70-90% (typically 80%)
  — Ge-68/Ga-68: 50-70% (typically 60%)
  — Sr-82/Rb-82: 85-95% (typically 90%)
• Result is a PREDICTION — actual activity must be measured with dose calibrator
  before clinical use!

Key features:
• Support for 3 major generator types with accurate half-lives
• Automatic daughter nuclide ingrowth time calculation
• Parent nuclide decay since calibration accounted for
• Patient dose count calculation
• Result categorization: EXCELLENT / ADEQUATE / MARGINAL / INSUFFICIENT
• Optional parameters with reasonable defaults
• Demo mode with clinically relevant examples for all generator types

Supported generators:
• Mo-99/Tc-99m: T½(Mo-99)=66 h, T½(Tc-99m)=6.01 h, efficiency=80%, dose=750 MBq
  Use: bone, cardiac, renal scintigraphy
• Ge-68/Ga-68: T½(Ge-68)=6480 h (271 days), T½(Ga-68)=1.13 h, efficiency=60%, dose=200 MBq
  Use: NET, prostate cancer PET
• Sr-82/Rb-82: T½(Sr-82)=605 h (25.2 days), T½(Rb-82)=0.0212 h (1.27 min), efficiency=90%, dose=1500 MBq
  Use: cardiac PET perfusion

💡 Usage tips:
1. Always use PARENT nuclide activity from generator certificate
   (do not confuse with activity in first eluate!)
2. For Mo-99/Tc-99m optimal time between elutions is 24 hours
3. For Ge-68/Ga-68 maximum activity reached 10-12 hours after elution
4. For Sr-82/Rb-82 elution possible every 10 minutes (short daughter half-life)
5. For INSUFFICIENT prediction — increase ingrowth time or order new generator
6. Document prediction before elution for audits

⚠️ Limitations:
• Does not account for column aging (decreasing efficiency over time)
• Does not account for generator storage temperature conditions
• Does not replace activity measurement before clinical use
• Assumes ideal elution (real-world variations ±10% possible)

Data sources:
• IAEA Technical Reports Series No. 466 (2009) — Radiopharmaceuticals for Positron Emission Tomography
• USP General Chapter <825> — Radiopharmaceuticals for Positron Emission Tomography
• Manufacturer specifications for commercial generators (Curium, IThemba LABS, etc.)
• Journal of Nuclear Medicine Technology — Generator elution efficiency studies

input.csv

BatchNumber,GeneratorType,GeneratorCalibrationActivityMBq,CalibrationDateTime,LastElutionDateTime,NextElutionDateTime,ElutionEfficiencyPercent,DosePerPatientMBq
TC99M-GEN-2026-001,Mo99-Tc99m,30000.0,2026-03-17T08:00:00,2026-03-18T08:00:00,2026-03-19T08:00:00,80.0,750.0
GA68-GEN-2026-001,Ge68-Ga68,1850.0,2026-03-01T08:00:00,2026-03-18T08:00:00,2026-03-18T14:00:00,60.0,200.0
RB82-GEN-2026-001,Sr82-Rb82,3700.0,2026-03-10T08:00:00,2026-03-18T08:00:00,2026-03-18T09:00:00,90.0,1500.0

URS & FS — user requirements and functional specification

This document defines user requirements and functional specification for the quality-control utility. It supports deployment discussion, IQ/OQ preparation and QC workflow integration.

Utility: GeneratorElutionPredictorAPI / object: Generator Elution PredictorCategory: Radiopharmaceuticals

1. Scope

The Generator Elution Predictor utility is used for Generator Elution Predictor. The actual input.csv is the source of truth for the input structure; control criteria are defined by the executable and the domain description.

The utility does not use machine learning; decisions are produced by deterministic rules.

Categories: Radiopharmaceuticals

Tags: decay correction, endotoxins, PET, radionuclide purity, radiopharma, SPECT, sterility

2. Execution modes

GeneratorElutionPredictor.exe                            → demo mode (console output)
GeneratorElutionPredictor.exe input.csv output.json      → calculate with your data

3. Key controlled areas

  • purity and impurities
  • microbiology and pathogens
  • pH and physicochemical parameters
  • activity, decay and radiochemical purity

4. Domain limits and critical parameters

  • ⚠️ IMPORTANT: Result is a PREDICTION and does NOT replace activity measurement
  • ⚠️ CRITICAL:
  • Utility uses PHYSICAL decay model accounting for transient equilibrium
  • Formula: A_d(t) = A_p(0) × [λ_d / (λ_d - λ_p)] × [1 - e^(-(λ_d - λ_p)×t)] × e^(-λ_p×t)
  • Requires knowledge of PARENT nuclide activity at generator calibration
  • Elution efficiency varies by generator type and method:
  • — Mo-99/Tc-99m: 70-90% (typically 80%)
  • — Ge-68/Ga-68: 50-70% (typically 60%)
  • — Sr-82/Rb-82: 85-95% (typically 90%)
  • Result is a PREDICTION — actual activity must be measured with dose calibrator
  • Support for 3 major generator types with accurate half-lives
  • Automatic daughter nuclide ingrowth time calculation
  • Parent nuclide decay since calibration accounted for
  • Patient dose count calculation
  • Result categorization: EXCELLENT / ADEQUATE / MARGINAL / INSUFFICIENT
  • Optional parameters with reasonable defaults
  • Demo mode with clinically relevant examples for all generator types
  • Mo-99/Tc-99m: T½(Mo-99)=66 h, T½(Tc-99m)=6.01 h, efficiency=80%, dose=750 MBq
  • Ge-68/Ga-68: T½(Ge-68)=6480 h (271 days), T½(Ga-68)=1.13 h, efficiency=60%, dose=200 MBq
  • Sr-82/Rb-82: T½(Sr-82)=605 h (25.2 days), T½(Rb-82)=0.0212 h (1.27 min), efficiency=90%, dose=1500 MBq
  • 1. Always use PARENT nuclide activity from generator certificate
  • 2. For Mo-99/Tc-99m optimal time between elutions is 24 hours
  • 3. For Ge-68/Ga-68 maximum activity reached 10-12 hours after elution
  • 4. For Sr-82/Rb-82 elution possible every 10 minutes (short daughter half-life)
Limits stated in the description must be verified against the current approved specification, pharmacopoeial monograph and registration dossier before production use.

5. URS — user requirements

IDRequirementCriticalityAcceptance criterion
URS-001The system shall accept an input.csv file for Generator Elution Predictor with the exact columns listed in the “Input data contract” section.HighA file with the correct header is processed without manual editing; missing mandatory columns produce FAIL/import error.
URS-002The system shall support execution without arguments in demo mode and execution with input.csv output.json for user data.MediumBoth execution scenarios produce a predictable result or clear diagnostic error.
URS-003The system shall perform rule-based controls for: purity and impurities, microbiology and pathogens, pH and physicochemical parameters, activity, decay and radiochemical purity.HighEach controlled parameter receives a status and message; the result does not depend on hidden Excel formulas or ML.
URS-004The system shall preserve traceability between batch/lot, source values, applied rules and final verdict.HighOutput includes batch identifier, source values, parameter statuses and critical findings.
URS-005The system shall generate machine-readable output.json for LIMS/ELN/MES, batch record and QA/QC review.HighJSON contains overall status, check array, warnings, failures and source-file reference.
URS-006The system shall support use in the client validation package: URS/FS, IQ/OQ preparation, installation and operational scenario checks.HighThe document, test scenarios and reproducible CSV/JSON flow are suitable for audit and internal approval.
URS-007The system shall clearly separate technical data errors from specification nonconformities.MediumSchema/type errors are not mixed with pharmacopoeial deviations and are reported separately.

6. input.csv data contract

The source of truth for the input schema is the actual input.csv header. Column names are technical identifiers and are not translated.

#ColumnTypeUnitDescriptionSampleControl rule
1BatchNumberidentifieras specifiedBatch NumberTC99M-GEN-2026-001mandatory field; used for batch/lot traceability
2GeneratorTypetextas specifiedGenerator TypeMo99-Tc99mmandatory value; format and acceptability are checked by the utility
3GeneratorCalibrationActivityMBqdecimalMBqGenerator Calibration Activity MBq30000.0mandatory numeric value; rule comparison is performed by the utility
4CalibrationDateTimedate/timeas specifiedCalibration Date Time2026-03-17T08:00:00mandatory value; format and acceptability are checked by the utility
5LastElutionDateTimedate/timeas specifiedLast Elution Date Time2026-03-18T08:00:00mandatory value; format and acceptability are checked by the utility
6NextElutionDateTimedate/timeas specifiedNext Elution Date Time2026-03-19T08:00:00mandatory value; format and acceptability are checked by the utility
7ElutionEfficiencyPercentdecimal%Elution Efficiency %80.0mandatory numeric value; rule comparison is performed by the utility
8DosePerPatientMBqdecimalMBqDose per Patient MBq750.0mandatory numeric value; rule comparison is performed by the utility

CSV example

BatchNumber,GeneratorType,GeneratorCalibrationActivityMBq,CalibrationDateTime,LastElutionDateTime,NextElutionDateTime,ElutionEfficiencyPercent,DosePerPatientMBq
TC99M-GEN-2026-001,Mo99-Tc99m,30000.0,2026-03-17T08:00:00,2026-03-18T08:00:00,2026-03-19T08:00:00,80.0,750.0

7. FS — functional specification

IDFunctionImplementation description
FS-001CLI entry pointThe executable GeneratorElutionPredictor.exe supports demo mode and input.csv output.json processing mode.
FS-002CSV parserThe import module reads CSV, validates header, column presence/order, value count and encoding. Decimal values are expected with a dot separator.
FS-003Field conversionEach column is converted to the expected type: identifier, text, decimal number, date/time or boolean flag.
FS-004Domain rule engineFor Generator Elution Predictor, explicit rules are applied: range, minimum, maximum, absence of prohibited flag, data completeness or calculation-based check.
FS-005Criticality handlingCritical violations produce FAIL; non-critical deviations and incomplete data produce WARNING; full conformance produces PASS.
FS-006JSON writeroutput.json stores overall status, per-parameter results, source values, warnings, failures and diagnostic messages.
FS-007Integration contractThe CSV → JSON format is stable for invocation from LIMS/ELN/MES, scheduled task or wrapper service.
FS-008Error handlingSchema error, missing file, non-numeric value or JSON write failure returns diagnosable error without silent PASS.

8. output.json contract

The output file must be suitable for automated processing, audit review and correlation with the source input.csv row.

{
  "utility": "GeneratorElutionPredictor",
  "api": "Generator Elution Predictor",
  "batchNumber": "TC99M-GEN-2026-001",
  "overallStatus": "PASS|WARNING|FAIL",
  "checkedAtUtc": "2026-05-18T00:00:00Z",
  "checks": [
    {
      "parameter": "BatchNumber",
      "value": "TC99M-GEN-2026-001",
      "unit": "as specified",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "GeneratorType",
      "value": "Mo99-Tc99m",
      "unit": "as specified",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "GeneratorCalibrationActivityMBq",
      "value": "30000.0",
      "unit": "MBq",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "CalibrationDateTime",
      "value": "2026-03-17T08:00:00",
      "unit": "as specified",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "LastElutionDateTime",
      "value": "2026-03-18T08:00:00",
      "unit": "as specified",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "NextElutionDateTime",
      "value": "2026-03-19T08:00:00",
      "unit": "as specified",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "ElutionEfficiencyPercent",
      "value": "80.0",
      "unit": "%",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "DosePerPatientMBq",
      "value": "750.0",
      "unit": "MBq",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    }
  ],
  "criticalFindings": [],
  "sourceFile": "input.csv"
}

9. OQ/PQ test scenarios

IDScenarioExpected result
TC-001Valid CSV with expected header and sample rowAll rows are processed; output contains PASS/WARNING/FAIL and parameter-level detail.
TC-002A mandatory input.csv column is missingImport is rejected or the row receives FAIL with schema reference.
TC-003A numeric field contains text or a blank valueType conversion error is recorded; the result is not hidden as PASS.
TC-004A parameter is outside specification or critical limitCritical parameters produce FAIL; non-critical deviations produce WARNING according to the rule.
TC-008Incorrect activity, reference time or radiochemical purityFAIL/WARNING is produced with calculation traceability.

10. QA/QC, CSV and change control

  • Before production use, the client records executable version, checksum, specification/monograph version, test CSV, expected JSON and IQ/OQ results.
  • Column names must not be changed without updating the validator and test scenarios.
  • The source CSV, output.json and utility version should be stored together as an evidence package.
  • Any change in control rules must go through change control and repeated OQ scenario verification.

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Tumour imaging, PSMA/FAPI/receptor tracers, immuno-PET, targeted radionuclide therapy and radioembolization.

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